Medical Writing

Expect clarity, compliance, and quality. Expect more.

At TFS HealthScience we believe that the quality of documentation can influence the flow of a clinical study. That’s why we are dedicated to providing you the documents you need to support your drug’s development journey with confidence.

TFS Medical Writing at a glance

Our medical writers provide you documents written with clarity in the languages you require and compliant with all ICH guidelines and regulatory requirements. They are experienced in writing for key therapeutic areas covering all phases of clinical development including real-world evidence.

Cooperation, continuity, clarity

The global medical writing team is made up of professionals, including MDs and others with advanced training in health science such as biomedics, and biologists. As quality EMA- and FDA-compliant documentation writing is imperative to us, they were chosen because of their strong research background, excellent language skills, and knowledge of biostatistics. Many are members of the European Medical Writers Association (EMWA).

Our writers tend to work with us for years, which enables us to provide continuity and experience to our customers. Half of our medical writers have more than ten years of experience.

For us, experience means efficiency, and clinical trials are incredibly time-sensitive. Usually, you can expect the first drafts of protocol and CSR in four to five weeks. Further versions can be delivered within five and ten working days after receiving your comments.

Throughout the trial, TFS medical writers cooperate closely with other teams involved in the study so you can expect clarity, accuracy, and compliance in every document.

Medical writing for clinical trials

Our expert team of writers supports you in every step of the study from beginning to end. They are skilled in writing protocols and CSRs with a complete scope of study types, depending on the main goal of your study. Following is a list of the types of documents our medical writers produce for customers:

Regulatory Writing

  • Clinical development plans
  • Clinical study protocols
  • Clinical study reports
  • Posting of clinical trial results (EudraCT and Clinicaltrials.gov)
  • Medical review data
  • Investigator brochures
  • CTD clinical overview
  • Investigational Medicinal Product (IMP) Dossiers
  • Investigational New Drug (IND) Dossiers
  • Transparency and Disclosure of Data in Clinical Trials (EMA policy 0070)
  • Clinical evaluation reports
  • Aggregated safety reports
  • Integrated summaries of safety/efficacy (ISS/ISE)
  • Lay summary
  • Briefing documents

Medical Communications

TFS medical writers can help you translate complex data and concepts into messages that people can understand.

  • Communication plans (manuscripts, abstracts, posters, oral communications)

  • Advisory board reports and scientific congress reports

  • Educational and marketing materials, including product monographs and slide kits

  • Medical information

  • Systematic reviews and meta-analysis

  • Web content

Real World Evidence (non-interventional studies) support

Our medical writers have a wide range of experience in non-interventional studies, including:

  • Epidemiological studies

  • Post-authorization safety studies (PASS)

  • Post-authorization effectiveness studies (PAES)

  • Health outcomes research studies

  • Health economic studies

Choose TFS Medical Writing to support the success of your study

We take pride in our documents being accepted by our clients for submission-ready issues or health authority validation issues.

  • 98% Ethics Committees and Health Authorities authorizations/approvals of study protocols
  • More than 100 marketing materials reviewed and prepared, including slide kits, product monographs, and training materials
  • More than 20 manuscripts accepted in peer-reviewed English language journals annually (85% in international journals with an average impact factor around 5.0)
  • More than 100 congress presentations delivered annually
  • 99% acceptance of abstracts, posters, and oral communications

The expertise and flexibility of our writing team allows us to support you in both a full-service project and in the scope of single services you may need. We take pride in the quality, clarity, and compliance of our writing. Contact us to experience the difference of a TFS partnership. Expect more.